RightFit
RecruitingPhase 2

Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Two-Part Study to Evaluate the Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well tonlamarsen lowers blood pressure and how safe it is. It is for adults with heart, blood vessel, or kidney disease who had very high blood pressure around a recent hospital stay.

The purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who were recently hospitalized and concurrently experienced an episode of acute severe hypertension.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older, weigh at least 50 kg (about 110 pounds), and have a body mass index (BMI) of 45 or less. BMI measures weight in relation to height.
  • Ready to leave the hospital for home, or went home from the hospital within the past 7 days.
  • Were checked or treated for very high blood pressure during that hospital stay. A health care provider recorded a top number of at least 180 or a bottom number of at least 110 within 24 hours before admission or during the first 24 hours in the hospital.
  • Have an average resting blood pressure top number of at least 145 at both the screening and randomization visits.
  • Have a known disease of the heart, blood vessels, or kidneys.

Who can't join

  • Have a known history of high blood pressure caused by another medical condition.
  • Had cancer that needed treatment within the past 5 years. Exceptions are successfully treated basal or squamous cell skin cancer, or cancer limited to the surface cells of the cervix.
  • Have a thyroid problem that is medically important.
  • Were hospitalized for a stroke, heart attack, or a procedure to restore blood flow to the heart within 30 days before screening.
  • Have a history or clear signs of cirrhosis (liver scarring) or another serious liver disease.
  • Have ALT or AST liver blood test levels more than twice the upper limit of normal.
  • The most recent hospital stay was for a condition not related to the heart, blood vessels, or kidneys.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: * Age 18 or older, body weight ≥ 50 kg with BMI ≤45.0 kg/m2 * Ready for discharge or recently discharged from the hospital to home (within the past 7 days) during which evaluation and/or treatment of acute severe hypertension (documented SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg) occurred, as measured by a healthcare provider (HCP) within the 24 hours preceding hospitalization or during the initial 24 hours of hospitalization * At Screening and Randomization visit, average resting office systolic blood pressure ≥ 145 mmHg * Presence of established cardiovascular or renal disease Key Exclusion Criteria: * Has known history of secondary hypertension * Any malignancy requiring treatment within 5 years (except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated) * Has abnormal thyroid function with clinical significance * Recent hospitalization for stroke, myocardial infarction or coronary revascularization within 30 days prior to screening * History of and/or obvious clinical signs or symptoms of cirrhosis or other significant liver disease * Alanine aminotransferase or aspartate aminotransferase \>2 x upper limit of normal * Most recent hospitalization was for non-cardiovascular or non-renal conditions

Study sites (13)

CO

FL

IL

MI

NY

OH

SC

TN

TX